Endoscopy refers to looking inside the human body for medical reasons. Endoscopy may be performed using an instrument called an endoscope. Endoscopy is a minimally invasive diagnostic medical procedure used to evaluate the interior surfaces of an organ by inserting a small tube into the body, often, but not necessarily, through a natural body opening or through a relatively small incision. Through the endoscope, an operator may observe surface conditions of the organs, including abnormal or diseased tissue such as lesions and other surface conditions. The endoscope may have a rigid or a flexible tube and, in addition to providing an image for visual inspection and photography, the endoscope may be adapted and configured for taking biopsies, retrieving foreign objects, and introducing medical instruments to a tissue treatment region referred to as the work site. Endoscopy is a vehicle for minimally invasive surgery.
Laparoscopic surgery is a minimally invasive surgical technique in which operations are performed through small incisions (usually 0.5-1.5 cm), keyholes, as compared to larger incisions needed in traditional open-type surgical procedures. Laparoscopic surgery includes operations within the abdominal or pelvic cavities, whereas keyhole surgery performed on the thoracic or chest cavity is called thoracoscopic surgery. Laparoscopic and thoracoscopic surgery belong to the broader field of endoscopy.
A key element in laparoscopic surgery is the use of a laparoscope: a telescopic rod lens system that is usually connected to a video camera (single-chip or three-chip). Also attached is a fiber-optic cable system connected to a “cold” light source (halogen or xenon) to illuminate the operative field, inserted through a 5 mm or 10 mm cannula to view the operative field. The abdomen is usually insufflated with carbon dioxide gas to create a working and viewing space. The abdomen is essentially blown up like a balloon (insufflated), elevating the abdominal wall above the internal organs like a dome. Carbon dioxide gas is used because it is common to the human body and can be removed by the respiratory system if it is absorbed through tissue.
Minimally invasive therapeutic procedures to treat diseased tissue by introducing medical instruments to a tissue treatment region through a natural opening of the patient are known as Natural Orifice Translumenal Endoscopic Surgery (NOTES)™. In general, there are a variety of systems for inserting an endoscope through a natural opening in the human body, dissecting a lumen, and then, treating the inside of the abdominal cavity. For example, in U.S. Pat. No. 5,297,536, which is incorporated by reference herein, a sample treatment system is disclosed. This system is comprised of a dissecting device for perforating a lumen wall; an endoscope insert member for inserting an endoscope, a tube, an endoscope, and a pneumoperitoneum device for insufflating the abdominal cavity; and a closing device.
When surgery of the inside of the abdominal cavity is carried out using this system, the endoscope insert member and tube are first inserted through a natural opening in the human body (mouth, anus, vagina, etc.) and the tube may be absorbed to a required organ wall by vacuum pressure, thus being fixed thereon. Next, a pneumoperitoneum needle is inserted and the abdominal cavity is insufflated. Then, the dissecting device is inserted and the organ wall is perforated. After surgery of the inside of abdominal cavity is complete, the perforation in the organ wall may be closed by an O-ring, and the endoscope and tube are withdrawn from the body.
Many different medical conditions, including hernias, may be addressed transluminally using endoscopic techniques. A hernia is a weakening of the musculofascial tissues defining the structural wall of a body cavity such as the abdomen, resulting in a gap through which tissues can protrude. Typically a sac is formed confining the tissues at the musculofascial defect, which protrudes from the plane of the tissue wall. There is a possibility of constriction of the neck of the sac, and life-threatening infection if the hernia remains untreated.
A weakening or separation of the musculofascial tissues due to any cause can develop into a hernia. For example scarring from a previous incision or other trauma of the abdominal wall can develop into a hernia, or a hernia can form at the site of a passage through the musculofascial tissue, the passage becoming enlarged, for example, due to pressure of the viscera during muscular exertion. There are various forms of hernias, the inguinal hernia being a common example wherein the abdominal viscera and peritoneal sac protrude through the floor of the inguinal cavity at the point where the musculofascial tissue is relatively weakened due to the passage of the spermatic duct (in males) or the femoral blood vessels and the round ligament (in females). Another common site of a hernia is the umbilicus. Hernias can also develop in the diaphragm, and elsewhere.
Another form of hernia is a ventral hernia. When a ventral hernia occurs, it usually arises in the abdominal wall where a previous surgical incision was made. In this area the abdominal muscles have weakened thereby resulting in a bulge or a tear. The inner lining of the abdomen pushes through the weakened area of the abdominal wall to form a balloon-like sac. A loop of intestines or other abdominal contents may be pushed into the sac.
Hernias have been repaired surgically by suturing across the musculofascial defect to draw the opposite sides of the defect together, the sutures bridging across the defect. However, such a repair is not suitable at hernias occurring at the site of a passage for ducts, blood vessels or the like. Moreover, pulling the sides of the defect inwardly results in tension on the musculofascial tissue via the sutures. The site of the sutures defines a weakening of the tissue and leads to a high rate of recurrence of the hernia at the sutured edge of a previous repair.
According to one technique for repairing hernias, a patch having sufficient strength to resist the tendency of the sac to protrude is placed over the defect and sutured to the musculofascial tissue. This technique avoids tension on the musculofascial tissues and has been shown to be successful in minimizing recurrence of the hernia. Various materials have been used in experimental or clinical hernia repairs, including for example polypropylene mesh, DACRON® fabric, tantalum gauze, and the like. Such technique may be performed using an open procedure which relies on cutting the abdominal section of the patient. The patch is placed in between the peritoneum and the skin. Besides having a relatively large incision site, the patch may eventually migrate through the peritoneum, for example, and adhere to the bowel.
Hernia repairs have been undertaken by laparoscopic techniques. With a laparoscopic technique, however, a plurality of smaller incisions must be made to the patient's abdominal section in order to introduce the various laparoscopic tools into the peritoneal cavity. Through the incisions, a patch may be introduced and attached to the inner abdominal wall to address the hernia. The patch is attached through various techniques, such as clips, sutures, or tacks. While less invasive then open-type surgery, the incisions, or ports, necessary for the laparoscopic procedure are susceptible to the formation of future ventral hernias.
Repairing a hernia transluminally through endoscopic techniques reduces the likelihood of recurring ventral hernias by eliminating the need to create external ports during the procedure. Using this technique, the endoscope, along with the necessary tools and devices, are introduced into the body via a natural orifice and then the hernia site is accessed transluminally. If a mesh patch is used to treat the hernia, it must be introduced to the hernia site while maintaining its sterilization.
Accordingly, in the field of endoscopy, there remains a need for improved methods and devices for delivering a sterile appliance, such as a mesh patch, to a surgical site while maintaining the sterilization of the appliance.